Kornimate/medical-research-clean huggingface dataset:
evaluating the rationality of the international guideline about selective coverage of level ib in ctv with npc

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study was to evaluate its rationality in real-world data and provide clinical evidence for the refinement of nodal ctv delineation in nasopharyngeal carcinoma(npc).

intensity-modulated radiation therapy (imrt) has gradually replaced two-dimensional radiation therapy as it offers improved target conformity. xerostomia is still the most common side effect of radiotherapy in patients with npc treated with imrt. most stimulated saliva is secreted by the parotid glands (pgs), while the submandibular glands (smgs) produce most of the unstimulated saliva and mucins, which may influence the degree of a dry mouth sensation.there are still differences in the understanding of nasopharyngeal cancer experts at home and abroad on the delineation of clinical target volumes., suitable criteria for elective irradiation of neck level ib need to be re-evaluated.therefore, we conducted a retrospective study to assess the feasibility of recommendation to level ib in the international guideline for delineation of clinical target volumes.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed npc by biopsy (clearly recorded in the pathology report or medical history) ; 2. no evidence of distant metastasis at initial diagnosis and receiving radical imrt in our center 3. the following conditions: ① level ib metastasis, ② involvement of the submandibular gland, ③ involvement of structures that drain to level ib as the first echelon site ( the oral cavity, anterior half of nasal cavity involvement) ④ involvement of level ii lns with extracapsular extension（because the judgment of extracapsular invasion is greatly influenced by subjective factors, this study only include patients who had high grade ene(g2/g3 as demonstrated in our previous study: oral oncol. 2019 dec;99:104438.)⑤ level ii nodal involvement with maximum nodal axial diameter greater than 2 cm. 4. all patients who were treated at lin shaojun's attending group from june 2005 to december 2012. 5. presence of complete baseline magnetic resonance imaging data of the nasopharyngeal skull base and neck and treated in our center at initial diagnosis . exclusion criteria: 1. disease progression during imrt; 2. fail to obtain tumor efficacy evaluation information in the medical records of the research center; 3. previous malignancy or other concomitant malignant disease; 4. receiving blind treatment in clinical research.
tolerability and quality of life study in participants who switched to avonex pen

Conditions: Relapsing-Remitting Multiple Sclerosis; Clinical Isolated Syndrome (CIS); Multiple Sclerosis

Summary: to evaluate treatment tolerability, adherence and quality of life (qol) over 1 year in ms (multiple sclerosis) participants who have been switched - due to persistent tolerability issues, particularly injection problems - from a subcutaneous injectable disease-modifying treatment (dmt) given several times a week (rebif, betaferon or copaxone) to once weekly avonex 30 μg given intra-muscularly. avonex will be applied by the injection device avonex pen.


Eligibility criteria:
key inclusion criteria: * continuous treatment with rebif, betaferon or copaxone over at least the past year. * injections site tolerability issues documented in medical records or by a nurse at inclusion. * clinically stable (free from relapses and 6-month confirmed disability progression for at least 6 months) while on therapy. * documented neurological history at least for the year prior to study entry. * qualification for avonex® (avonex pen) according to the approved indication (clinical isolated syndrome) or relapsing remitting multiple sclerosis (rrms). * acceptance of magnetic resonance imaging. key exclusion criteria: * patients who have previously entered this study. * treatment with avonex during the 12 months prior to the study. * one or more relapses and/or 6-month confirmed disability progression during the 6 months prior to the study. * patient on betaferon with neutralizing antibodies (nabs) more than 400 tru (tenfold reduction units) and patients on rebif with nabs with more than 100 tru. * secondary progressive multiple sclerosis. * primary progressive multiple sclerosis. * pregnancy or breast feeding. * history of severe depression or attempted suicide or current suicidal ideation. * medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study. * uncontrolled seizure disorder. * myopathy or clinically significant liver disease. * inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study. * known hypersensitivity to interferon-beta or other human proteins including albumin. * a history of drug abuse in the 6 months prior to screening. * treatment with any of the following in the 30 days before day 1: systemic corticosteroids, acth, or other investigational drugs. * participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study. * likelihood of requiring treatment during the study period with drugs not permitted by the study protocol. note: other protocol-defined inclusion/exclusion criteria may apply.
evaluation of the role of ige responses to der p 1 and der p 2 in chinese house dust mite-allergic patients

Conditions: Asthma; Allergic Rhinitis; Conjunctivitis; Atopic Dermatitis

Summary: one hundred patients were enrolled, based on sensitization and doctor-diagnosed allergy to hdm. questionnaires were administered to document demographic and clinical characteristics. serum ige reactivity todermatophagoides pteronyssinus (dp) extract, der p 1, der p 2 and der p 10 was measured by immunocap.

background: the role of specific ige (sige) against der p 1and der p 2 in chinese patients with house dust mite (hdm)allergy has not yet been well investigated.methods: one hundred patients were enrolled, based on sensitization and doctor-diagnosed allergy to hdm. questionnaires were administered to document demographic and clinical characteristics. serum ige reactivity todermatophagoides pteronyssinus (dp) extract, der p 1, der p 2 and der p 10 was measured by immunocap.

Eligibility criteria:
inclusion criteria: * hdm-allergic patients reporting allergic rhinitis, conjunctivitis, asthma and/or atopic dermatitis and who had never undergone immunotherapy, were enrolled if they were sensitized to dp as judged by immunocap ( ≥ 1 ku/l) and/or skin reaction index (sri)by skin-prick test (spt, a wheal diameter ≥ 0.5 mm). exclusion criteria: * patients who refused to participate in the study.

Keywords: house dust mite der p 1 der p 2 china
sodium intake in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: recently, it has been shown that salt (clna, sodium chloride) can modulate the differentiation of human and mouse th17 cells. indeed, mice feed with high sodium diet were described to develop more aggressive course of eae (experimental autoimmune encephalitis). however, the role of sodium intake in ms has not been investigated. in this study we investigate the effect of sodium intake in multiple sclerosis (ms) clinical and radiological activity.


Eligibility criteria:
inclusion criteria: * subject is between 18 and 50 years old * subject has diagnosis of relapsing-remitting ms according to mcdonald criteria (2010) exclusion criteria: * patient who had hyponatremia in the last 90 days

Keywords: multiple sclerosis salt
prospective evaluation of a new molecular tool for early diagnosis of mucormycosis

Conditions: Mucormycosis

Summary: this study evaluates the performance (sensitivity, specificity, positive and negative predictive value values and likelihood ratios) of the dna detection test for the diagnosis of mucormycosis by comparing it to the routine tests such as ct scan aspects, histopathology, microscopy and fungal culture, in a test group of 52 patients including : * patients at high-risk according to the eortc/msg criteria (patients with prolonged severe neutropenia, receiving corticosteroids or t-cell suppressors, recipients of allogeneic hsct, or inherited severe immunodeficiency), * patients with other predisposing factors of invasive mould disease ( diabetes, aids, haematological malignancies or solid tumours, trauma, burns); patients already diagnosed with probable or proven mucormycosis irrespective of underlying conditions.

the patients eligible for this study will already be hospitalized with repeated monitoring of clinical and biological parameters. participation in the study will result in an additional sampling of blood (estimated volume 6 ml for each sampling) on day of suspicion of the mucormycosis and then twice a week up to a maximum of 8 weeks. vials will be added to the routine sampling of these patients (ie, at the time of routine sampling for galactomannan antigemia), and no new sampling procedure will be required.

Eligibility criteria:
inclusion criteria: * suspicion of invasive mould infection * in a patient at high risk according to the eortc/msg criteria updated in 2008 (patients with prolonged severe neutropenia, receiving corticosteroids or t-cell suppressor, recipients of allogeneic hsct, or inherited severe immunodeficiency) * or in a patient with other predisposing factors of invasive mould disease ( diabetes, aids, haematological malignancies or solid tumours, trauma, burns). * patients already diagnosed with probable or proven mucormycosis irrespective of underlying conditions, including patients referred from other centers. * only adult patients (18 years or older) will be included exclusion criteria: * age : under 18 years * patients previously included in the trial with a diagnosis of mucormycosis. however patients previously entered in the trial with a diagnosis other than mucormycosis will be eligible for re- new inclusion. * presence of any medical condition that would not allow collection of blood samples for the qpcr test. * history of documented, successfully treated, prior mucormycosis. * protected people (pregnant women, minor, guardianship...)
a study of dbpr108 and metformin hydrochloride combination therapy in patients with t2dm

Conditions: Type 2 Diabetes Mellitus

Summary: this study aims to evaluate the efficacy and safety of dbpr108 tablets in combination with metformin hydrochloride in the treatment of type 2 diabetes mellitus. a total of 210 subjects will be randomly assigned in a ratio of 2:1 to receive metformin hydrochloride plus dbpr108 or metformin hydrochloride plus placebo.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes according to world health organization (1999) diabetes diagnosis standard; * age 18-75 years, men and women; * bmi 19-35 kg/m2; * hba1c 7.0%-9.5%; * before screening, a stable metformin dose（≥1000mg/day）should be maintained for at least 8 weeks. * signed informed consent from the patient; * agree to use contraceptive measures from the date of signing the informed consent to 1 month after the end of the last medication. exclusion criteria: * fpg \> 13.9 mmol/l; * insulin treatment required in the investigator's opinion; * administration of antidiabetic drugs (except for metformin) including insulin, rosiglitazone, pioglitazone, dpp-4 inhibitor, glucagon like peptide-1 (glp-1) receptor agonist for 8 weeks before screening; * acute complications of diabetes (including diabetic ketosis and ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma); * severe hypoglycemia; * serious diabetic complications (such as diabetic foot, etc.); * history of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.); * history of being allergic to dpp-4 inhibitors; * untreated hyperthyroidism and other diseases which may cause secondary hyperglycemia; * previous treatment with glucocorticoids (except for external use and inhalation) within 4 weeks before screening or may be used for more than 14 consecutive days during the study; * inflammatory bowel disease, partial intestinal obstruction or chronic bowel disease related to obvious digestive and absorption disorders; * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 3\*upper limit of normal (uln), or total bilirubin \> 1.5uln; * abnormal renal function; * white blood cells (wbc) \ 5.7 mmol/l; * hbsag, hbeag or hbcab positive, or any one of hepatitis c antibody, anti-hiv antibody and nonspecific antibody of treponema pallidum positive; * pregnant or lactating women; * history of alcohol or drug abuse; * participation in other clinical trials or administration of any other investigational drugs or devices within 3 months before screening; * significant unstable diseases; * any condition that in the investigator's opinion might render the patient unable to participate the trial.

Keywords: dbpr108 dipeptidyl peptidase-4 (dpp4) inhibitors metformin hydrochloride
intertribal talking circle for the prevention of substance abuse in native youth

Conditions: Substance Use

Summary: this project will evaluate an after-school substance abuse prevention intervention, compared to a standard substance abuse education program, targeting 6th grade ai youth in three ai communities: ojibwe/chippewa in minnesota, choctaw in oklahoma, and lumbee in north carolina. a community-based participatory research approach will be used to culturally and technologically adapt the intervention. a two-condition controlled study will evaluate the efficacy of the intervention to increase ai youth native self-reliance while decreasing ai youth substance use involvement. an adult training program second level intervention study will also be implemented to train tribal personnel from the three regional tribes on how to implement the intervention as a tribal program beyond the study period. effectiveness will be determined by a small partial cross-over randomized trial comparing the intervention to a wait-list control condition. process evaluations will focus on the future adoption and implementation of the intervention, and recommendations for sustainable adaptations.

the proposed study will consist of a 5-year plan: year 1 has been completed and consisted of strengthening and extending community partnerships in each community and collecting data that will inform the cultural adaptation and tailoring of the intervention; years 2, 3, and 4 will entail implementation by using a two-condition controlled study in which the culturally competent intervention is compared to standard care; and year 5 will consist of final data collection, analysis of results, dissemination of results to local communities, and finalization of a sustainability plan for each tribe. participants in the proposed study will consist of 540 male and female american indian 6th grade students who represent at least three different tribes - choctaw, ojibwe/ chippewa, and lumbee, in three different regions of the u.s. participants will also include 70 tribal personnel (adults 18 and over) who be trained to implement the intervention in years 3 \& 4 of the project. finally, 15-20 stakeholders and community partnership members will be interviewed at various stages of this project.

Eligibility criteria:
inclusion criteria: * inclusion criteria for youth participants include: * ail students enrolled in the 6th grade at each of the 3 regions * active parental consent * student willingness to participate and signed assent. inclusion criteria for adult participants include: adults over 18 years of age currently employed as personnel, educators, and counselors at tribal schools among the three regions. exclusion criteria: * exclusion criteria include students who are not identified as american indian, no active parental consent, and no signed assent.

Keywords: culturally tailored intervention american indian early adolescents prevention of substance use
tadalafil taken daily compared to placebo on improvement of getting and maintaining an erection and sexual quality of life

Conditions: Impotence

Summary: to determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner


Eligibility criteria:
inclusion criteria: male * history of erectile dysfunction (ed) for at least 3 months duration * anticipate having the same female partner willing to participate throughout the study * at least 18 years of age at visit 1 and agree to make at least 4 sexual attempts during the early phase of the study * adequate partner sexual function as determined by a female sexual function index * willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study exclusion criteria: * may not participate in the study if you have taken tadalafil previously. * history of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study. * have sexual partner not willing to complete the scales. * use of nitrates.
community based management of malnutrition

Conditions: Severe and Moderate Malnutrition

Summary: malnutrition is the leading cause of death in children in developing countries, especially pakistan. according to world health organization about 60% of all deaths, occurring among children aged less than five years in developing countries, could be attributed to malnutrition. community-based therapeutic care attempts to maximize population-level impact through improved coverage, access, and cost-effectiveness of treatment. such community-based nutrition packages can provide effective care to the majority of acutely malnourished children as outpatients, using techniques of community mobilization to engage the affected population and maximize coverage and compliance. children with sam without medical complications are treated in an outpatient therapeutic program with ready-to-use therapeutic food and routine medications. the ready-to-use therapeutic food (rutf) and fortified supplementary food has revolutionized the treatment of moderate and severe malnutrition. the advantage of these commodities is that they are ready-to-use paste which does not need to be mixed with water, thereby avoiding the risk of bacterial proliferation in case of accidental contamination.

aim: to evaluate the effectiveness of ready to use therapeutic food and food supplement (nutributter) in the treatment of moderate and severe malnutrition in rural pakistan when administered at community level primary objectives: * to assess the acceptability, feasibility and effectiveness of nutributter and fortified supplementary food (rutf) in the treatment of moderate malnutrition in children less than three years of age in community settings. * to assess the acceptability, feasibility and effectiveness of rutf in the treatment of severe malnutrition in children less than three years of age in community settings. methodology: study design: community based, step wedge randomized trial sample size estimation: total population of the study area: 60268. estimated under 5 years of age population: 9040 (assuming 15% of total population. estimated population between 6 months to 3 years: 4520 (assuming 50% of under 5 population) sample size for moderate malnutrition: it is estimated that the prevalence of moderately malnourished: 20% therefore 20% of 4520: 904. we anticipate recruiting 1000 cases (96 about 10% extra for any loss to follow-ups or drop outs) sample size for severe malnutrition: it is estimated that the prevalence of severe acute malnutrition is 8%. therefore 8% of 4520: 360. we anticipate recruiting 400 cases (40 about 10% extra for any loss to follow-ups or drop outs)

Eligibility criteria:
inclusion criteria: * born and eligible for inclusion within the study period. * presence of moderate to severe malnutrition. * ability of the parents or guardians to provide informed consent exclusion criteria: * presence of chronic debilitating illness. * residence outside of study areas. * inability or refusal of the parents or guardians to give informed consent, or refusal of assessment.

Keywords: rutf sam nutributter
pregnancy outcome in women with an iron deficiency in the first trimester

Conditions: Iron Deficiency

Summary: the primary aim of this retrospective, monocentric study with two parallel groups is to investigate pregnancy outcome in women with iron deficiency in the first trimester. it compares the pregnancy outcome between pregnant women with an iron deficiency and those without an iron deficiency in the first trimester. the study group are pregnant women with a diagnosed iron deficiency in the first trimester, a total of 227 pregnant women. the control group consists of 486 pregnant women without first-trimester iron deficiency. matching criteria include parity and maternal age. data from patient files of pregnant women who were treated in the women's clinic, university hospital basel between 2017 and 2019 are analyzed.


Eligibility criteria:
inclusion criteria: * pregnant women with a documented iron deficiency in the first trimester * pregnant women with normal hematological parameters and iron status in the first trimester * treated at the women's clinic, university hospital in basel exclusion criteria: * pregnant women with a documented rejection

Keywords: iron deficiency anemia of pregnancy pregnancy outcome perinatal risk maternal risk
dupilmuab for atopic dermatitis monitored with noninvasive imaging.

Conditions: Eczema; Atopic Dermatitis

Summary: the study is trying to answer the following question: "can we use non-invasive imaging to evaluate the response of atopic dermatitis (eczema) to dupixent (dupilumab)?"

participating in this research will allow the subject to undergo a noninvasive imaging alternative to conventional monitoring in response to a biologic. normally, subjects would undergo a clinical examination, serial photography, and possible biopsies to assess the progression of the disease. this study will get rid of the need for a biopsy but will require multiple scans with non-invasive imaging. this research examines a new approach to monitoring response to a biologic drug used for atopic dermatitis, and can also, be used to grade disease severity without the need for a biopsy.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * atopic dermatitis (ad) affecting ≥10% body surface area (bsa) at baseline * iga score ≥3, on the iga scale of 0-4 at baseline * eczema area and severity index (easi) score of ≥16 at baseline exclusion criteria: * prior treatment with dupilumab (regn668/sar231893) * treatment with tcs or topical calcineurin inhibitors (tci) within 2 weeks before the baseline visit * bodyweight \<30 kg (65lb) at baseline * known or suspected immunodeficiency including human immunodeficiency virus (hiv) infection * pregnancy, breastfeeding or planning to become pregnant or breastfeed during the study

Keywords: dermatitis dupilumab inflammatory skin diseases itch relief biologic